Phase 2 N=260 Randomized Treatment

Local mEHT + TCM Versus Intraperitoneal Chemoinfusion in Treatment of Malignant Ascites: Phase II RCT

Peritoneal Neoplasms · Ascites · Yang Deficiency · Yin Deficiency

Bottom Line

View on ClinicalTrials.gov: NCT02638051 ↗

Enrolled (actual)

260

Serious AEs

0.0%

Results posted

Mar 2016

Primary outcome: Primary: Objective Response Rate (ORR) — 77.7; 63.8 percentage of participants — p=0.0140

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Modulated Electro-Hyperthermia (mEHT) (Device); TCM Herbal Decoction (Shi Pi) (Dietary_supplement); IPCI (CDDP+5FU) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Galenic Research Institute Ltd
Primary completion: Dec 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Objective Response Rate (ORR)	77.7; 63.8	0.0140 sig
SECONDARY Adverse Events Rate (AER)	3; 16; 3; 5; 0; 3	0.0016 sig
SECONDARY Quality of Life (QoL)	49.2; 32.3; 40.8; 52.3; 10; 15.4	0.0053 sig

Summary

This trial studies efficacy and safety of combination of modulated electro-hyperthermia (mEHT) with Traditional Chinese Medicine (TCM) in treatment of peritoneal carcinomatosis with malignant ascites versus standard chemoinfusion (CDDP+5FU).

Eligibility Criteria

Inclusion Criteria

Pathologically confirmed PC with malignant ascites.
Karnofsky Performance Status (KPS) score ≥60%.
Normal function of bone marrow.
Predicted survival time >1 month.
Written informed consent.

Exclusion Criteria

Surgery within 3 weeks or not full recovery of postoperative suture.
Active bleeding or vascular occlusion in the mEHT treatment area.
Emotional instability.
Impossibility to place the patient into the mEHT machine.
Metallic implants or replacements in the treatment area.
Electronic implanted devices anywhere.
Missing or damaged heat-sense nerves or other field-sensitive issues in the treatment area.
Very low white blood cell count (<1.5×10(9)/L), agranulocytosis (<0.5×10(9)/L) or severe anemia.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02638051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.